[18F]FAPI-74 for Connective tissue disease-associated interstitial lung disease (CTD-ILD) | Systemic sclerosis | Rheumatoid arthritis | Sjögren's syndrome | Idiopathic inflammatory myopathy | Undifferentiated connective tissue disease

Inclusion criteria

• {"criterion_text":"- Female and male aged between 18 and 75 years\n- Signature of informed consent\n- A clinical diagnosis of SSc, RA, SS, IIM, or UCTD that must adhere to internationally accepted classification criteria\n- A high risk of ILD based on autoantibody profile, specifically: anti-Scl70+ or anti-RNAPIII+ for SSc, anti-CCP+ and/or RF+ for RA, anti-RoSSA+ and anti-LaSSB+ for primary SS, anti-synthetase+ for IIM. For UCTD patients, the enrollment criteria will be adapted to match those of Interstitial Pneumonia with Autoimmune Features (IPAF), with patients exhibiting one clinical feature of CTD and one serological domain criterion (e.g., ANA positive with nucleolar pattern, RF and anti-CCP positivity, anti-RoSSA and anti-LaSSB positivity, anti-Scl70 positivity) while not meeting the classification criteria for any other CTD\n- Evidence of ILD based on an HRCT documenting the presence of interstitial changes involving at least 10% of the parenchyma within the previous 6 weeks\n- Either naive to immunosuppressants or having been on a stable immunosuppressive regimen for the 3 months preceding FAPI PET/CT. Treatment with rituximab must be not administered in the previous 24 weeks\n- Specifically, patients that are candidates to BALF collection must have functional or radiological evidence of ILD deterioration to justify microbiological and cytological characterization of the lung environment before treatment upgrade"}

Exclusion criteria

• {"criterion_text":"- Current treatment with corticosteroids > 10 mg of prednisone\n- Women of childbearing potential tested positive at the urine pregnancy test performed just before FAPI PET/CT procedure\n- Pregnancy, breastfeeding, or intention to undergo pregnancy within 6 months from the PET/CT scan\n- Men who have a partner of childbearing age who intends or is likely to become pregnant in the 6 months following PET/CT\n- Claustrophobia and/or inability to tolerate PET acquisition that would have an impact on the collection of a good quality scan\n- Poor peripheral arterial and/or venous access that would interfere with radiopharmaceutical administration and/or blood sampling\n- Specifically, the patient’s candidate for BALF collection must not have contraindications to the procedure, namely severe refractory hypoxemia and/or O2 therapy, uncontrolled active bronchospasm, history of unstable angina, history of myocardial infarction, history of unstable arrhythmias, platelet count <20,000/mm3 in the preceding 4 weeks, international normalized ratio or activated partial thromboplastin time ratio >1.5 evaluated in the preceding 4 weeks\n- Clinical evidence of infection or positive microbiological tests on BALF analysis if performed\n- known allergy or hypersensitivity to any component of the FAPI tracer"}

Primary endpoints

• {"endpoint_text":"- The following measures will be evaluated in FAPI PET-CT: pattern and distribution of FAPI uptake, mean and maximum Standardized Uptake Value (SUV mean and SUV max) of pulmonary fibrotic lesions, fibrotic active volume (FAV), total fibrosis (calculated as the product of SUV mean and the fibrotic active volume), uptake ratio between fibrotic and healthy lung tissue. These measures will be compared between CTD-ILD patients with and without progressive phenotypes at the 12-month follow-up","definition_or_measurement_approach":"FAPI PET/CT-derived measures: pattern/distribution of uptake, SUV mean and SUV max of fibrotic lesions, fibrotic active volume (FAV), total fibrosis (SUV mean × FAV), and uptake ratio fibrotic vs healthy lung tissue; comparison between patients with and without lung functional progression at 12 months."}

Secondary endpoints

• {"endpoint_text":"- AI-collected measures of lung anatomy (including lung texture, airway, and vascular measures) and serum EV single-protein quantity and RNA expression measures","definition_or_measurement_approach":"AI-read HRCT outputs (lung texture, airway and vascular measures) and circulating extracellular vesicle (EV) proteomic and transcriptomic analyses (serum EV single-protein quantity and RNA expression)."}
• {"endpoint_text":"- Exploratory endpoint: BALF EV single-protein quantity and RNA expression measures","definition_or_measurement_approach":"Proteomic and transcriptomic characterization of extracellular vesicles from bronchoalveolar lavage fluid (BALF): single-protein quantification and RNA expression measures."}

Italy

Earliest CTIS Part Ii Submission Date

10-10-2024

Latest Decision Or Authorization Date

11-11-2024

Processing Time Days

32

Number Of Sites

1

Number Of Participants

35

Primary sponsor

Full Name

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy